Traditional Medicine vs Phytopharmaceuticals: What Are the Differences and How Are They Tested?
According to the Badan Pengawas Obat dan Makanan (BPOM), traditional medicine refers to materials or preparations derived from plants, animals, minerals, galenic preparations (extracts), or combinations of these materials that have been traditionally used for treatment and are applied according to the norms existing within society.
Traditional medicines are divided into three main categories: jamu, standardized herbal medicine (OHT), and phytopharmaceuticals. This classification is based on the level of scientific evidence, quality standards, safety, and applicable regulations.
Table of content:
- About Jamu
- Standardized Herbal Medicine (OHT)
- Phytopharmaceuticals
- How Are the Testing Standards Applied?
About Jamu
Jamu is the simplest and most commonly used form of traditional medicine in Indonesia. The efficacy of jamu is based on empirical experience or traditional use passed down through generations. In other words, its benefits are believed because it has been used by communities for a long time, although it has not undergone comprehensive modern scientific testing.
The raw materials used in jamu are generally not strictly standardized, although they must still comply with BPOM safety and quality requirements. Therefore, claims on jamu products usually use phrases such as “traditionally used to help…” rather than claiming to definitively cure diseases. Examples of jamu products include Tolak Angin and Sido Muncul Sari Kunyit.
Standardized Herbal Medicine (OHT)
Standardized Herbal Medicine (Obat Herbal Terstandar/OHT) is the next stage after jamu. In this category, the herbal raw materials have been standardized, and the products have undergone preclinical testing. Preclinical studies are generally conducted using laboratory animals or in vitro methods to evaluate the safety, toxicity, and preliminary effectiveness of herbal materials.
Raw material standardization is an essential aspect of OHT. The active compound content must remain consistent so that the product quality and therapeutic effects are maintained across every production batch. Examples of OHT products in Indonesia include Stimuno, Diapet, Lelap, and others.
Phytopharmaceuticals
Phytopharmaceuticals represent the highest category of traditional medicine. Phytopharmaceutical products have undergone complete testing, ranging from preclinical studies to clinical trials in humans. Because they are supported by strong scientific evidence, phytopharmaceuticals are often considered equivalent to modern evidence based medicines.
In addition, both the raw materials and finished products must be properly standardized. Clinical trials are conducted to ensure the effectiveness, safety, dosage, and potential side effects of the products in humans. This is what distinguishes phytopharmaceuticals from ordinary jamu.
Read also:
Jamu, Standardized Herbal Medicine, and Phytopharmaca: The Difference Between Those 3
How Are the Testing Standards Applied?
Testing of traditional medicines is conducted gradually according to each category. For jamu, testing mainly focuses on basic quality and safety. Common tests include organoleptic testing (color, odor, taste, and appearance), specific parameter testing (simplicia identification and marker compound levels), non specific parameter testing (moisture content, ash content, and drying shrinkage), microbial contamination testing, chemical contamination testing, testing for adulteration with synthetic medicinal chemicals (BKO), and simple stability testing.
For Standardized Herbal Medicine (OHT), the testing requirements are more comprehensive than those for jamu because the products must have preliminary scientific evidence regarding their safety and efficacy. In addition to all the basic tests required for jamu, OHT products also require stricter standardization of raw materials and extracts.
This standardization includes determining marker compound or active substance levels, chromatographic profiling, and ensuring consistency between production batches. Through standardization, the concentration of active compounds in the product can be maintained consistently, resulting in more reliable therapeutic effects.
Besides quality testing, OHT products must also undergo preclinical testing. Preclinical studies are performed both in vitro and in vivo using experimental animals. These tests aim to evaluate pharmacological activity, effectiveness, and safety before the products are used in humans. Common tests include acute toxicity, subchronic toxicity, and chronic toxicity studies to assess potential harmful effects of herbal ingredients.
Biological activity testing based on product claims is also conducted, such as anti inflammatory, antioxidant, antihyperglycemic, immunostimulant, or antibacterial activity tests. Meanwhile, phytopharmaceuticals have the highest testing standards among all traditional medicine categories.
In addition to meeting all requirements applied to jamu and OHT, phytopharmaceuticals must also undergo clinical trials in humans. Clinical trials are conducted in stages to evaluate safety, effectiveness, dosage, and potential side effects in human subjects.
Through these clinical studies, phytopharmaceutical claims are supported by stronger scientific evidence and can be medically justified. Phytopharmaceutical testing generally includes early phase and advanced phase clinical trials depending on the intended use of the product.
Furthermore, long term stability testing, analytical method validation, and stricter quality control throughout the manufacturing process are also required. Phytopharmaceutical products must be manufactured according to Good Traditional Medicine Manufacturing Practices (CPOTB) to ensure consistent quality, safety, and efficacy.
Because they undergo comprehensive scientific evaluation, phytopharmaceuticals are considered more reliable and may serve as standardized natural based therapeutic alternatives.
Ready to Elevate Your Herbal Product to Phytopharmaceutical Standards?
Moving from traditional herbal medicine to phytopharmaceutical status takes more than intention it requires a laboratory partner that understands regulatory requirements, applies validated testing methodologies, and delivers data that BPOM RI will accept.
IML Testing & Research is an ISO 9001:2015 accredited independent laboratory that has supported pharmaceutical and herbal industry players in navigating the full testing process from safety and efficacy to quality assurance with precision and efficiency. Reach out to our expert team today for a free consultation to map out the right testing roadmap for your product.
Author: Jihan
Editor: Alphi
References
Badan Pengawas Obat dan Makanan. (2023). Peraturan Badan Pengawas Obat dan Makanan Nomor 29 Tahun 2023 Tentang Persyaratan Keamanan dan Mutu Obat Bahan Alam. Jakarta: BPOM RI
Badan Pengawas Obat dan Makanan. (2024). Pedoman Pengkajian Obat Bahan Alam, Suplemen Kesehatan, dan Kosmetik.
